The following data is part of a premarket notification filed by Angeion Corp. with the FDA for Angeion Hemostasis Valve Introducer.
| Device ID | K894446 |
| 510k Number | K894446 |
| Device Name: | ANGEION HEMOSTASIS VALVE INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | ANGEION CORP. 13000 HIGHWAY 55 Plymouth, MN 55441 |
| Contact | Gregory G Brucker |
| Correspondent | Gregory G Brucker ANGEION CORP. 13000 HIGHWAY 55 Plymouth, MN 55441 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-11-30 |